Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

Amputation Clinical Trial

Official title:

Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06259695
• Other study ID #: STU00219525
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. The pool environment offloads body weight, which can improve comfort on a residual limb and increase confidence in activities outside of the pool. The properties of water also assist in strengthening exercises and reducing pain. Currently, most individuals do not have a prosthesis to use in the pool. Water specific prosthesis are often not covered by insurance and can be expensive. For someone that doesn't have a water specific prosthesis, they may not be able to do therapy tasks on two legs, limiting what activities or exercises can be performed. Through creating an adjustable prosthesis, it will allow persons with limb loss to have access to a water specific leg in a time efficient, cost effective, and safe manner for rehabilitation. This study involves a novel prosthesis for use in aquatic therapy. This novel design will have an adjustable circumference, residual limb length, and height, allowing a greater number of patients to use the prosthesis.

Description:

The goal of this project is to create and conduct a preliminary usability evaluation of a novel adjustable prosthesis for use in aquatic therapy for persons with a lower limb amputation at the transtibial level (LLTTA). It is hypothesized that this prosthesis will benefit both the patient and the therapist during aquatic therapy sessions, which will be evaluated through the following aims: Aim 1: Create a non-custom, adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level. Aim 2: Perform a pilot study (n=3) to quantity the usability of the prosthesis as a therapy tool.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: December 31, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-89 years
• Patients who have a unilateral transtibial amputation who are able to use a prosthesis
• Patients who currently participate in aquatic therapy at Shirley Ryan AbilityLab, or have completed aquatic therapy within the last six months, at Shirley Ryan AbilityLab

Exclusion Criteria:

• Pregnant women
• Children (<18 years old)
• Prisoners or institutionalized individuals
• Individuals who have the inability to give informed consent
• Participants with complicating health conditions that interfere with the study
• Participants with contraindications to aquatic therapy, as listed in Shirley Ryan AbilityLab's policy on aquatic therapy participation

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Adjustable Aquatic Therapy Prosthesis
We will recruit up to three participants, who will attend up to two fitting appointments lasting up to one hour to assist in the design development. After the design of the prosthesis is completed, participants will attend three, 30-minute, aquatic therapy sessions with a physical therapist trained in aquatic therapy and utilize the prosthesis.

Locations

Country	Name	City	State
United States	Shirley Ryan Ability Lab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Survey - Subject	The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Through study completion, an average of one year.
Secondary	Socket Comfort Score	Rating system to assess prosthesis socket comfort. Scale ranges from 0-10, with 0 being the least comfortable and 10 the most comfortable.	Through study completion, an average of one year.
Secondary	System Usability Survey - Physical Therapist	The System Usability Survey is a reliable tool for measuring the usability of a device. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Through study completion, an average of one year.